Advincula Delineator™ Uterine Manipulator with 3.0 cm Ultem® Koh-Efficient® AD750-KE30Recalls & reported problems
Coopersurgical, Inc. · Advincula Delineator™ Uterine Manipulator with 3.0 cm Ultem® Koh-Efficient® · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888937012743), received between Apr 23, 2025 and Apr 23, 2025 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Internal Organ Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY IN (B)(6) 2025. DURING THE PROCEDURE, THE UTERINE MANIPULATOR CAME OUT AND WAS REPLACED WITH A DIFFERENT BRAND OF UTERINE MANIPULATOR. AFTER BEING REPLACED, THE SECOND MANIPULATOR STILL DID NOT HOLD. THE UTERINE MANIPULATOR MANUFACTURER WAS CALLED DURING THE CASE TO HELP TROUBLESHOOT. WHEN REINSERTING THE MANIPULATOR, THE UTERUS WAS PERFORATED WITH THE TIP OF THE MANIPULATOR. DIFFICULT UTERINE MANIPULATION CAUSED URINE TO HAVE RED TINGE. DOCTOR WAS CALLED TO DO A CYSTOSCOPY AFTER VAGINAL CUFF WAS CLOSED. BOTH URETERS WERE OPEN. USER CLAIMS THAT THE DEVICE FAILED, BUT THE NATURE OF THE FAILURE WAS NOT SPECIFIED. ATTEMPTS WERE MADE, BUT NO ADDITIONAL INFORMATION IS AVAILABLE. AD750-KE30 UTERINE MANIPULATOR (B)(4).
Patient problems: Internal Organ Perforation
MAUDE report 21890686 ↗
Other Culdoscope (And Accessories) devices
- GelPOINT V-Path C2A12Applied Medical Resources Corporation · Culdoscope (And Accessories)24 reports
- RUMI II Koh-Efficient KC-RUMI-30Coopersurgical, Inc. · Culdoscope (And Accessories)12 reports
- RUMI II Koh-Efficient KC-RUMI-35Coopersurgical, Inc. · Culdoscope (And Accessories)8 reports
- Arch Koh-Efficient KC-ARCH-35Coopersurgical, Inc. · Culdoscope (And Accessories)4 reports
- GelPOINT V-Path C2A15Applied Medical Resources Corporation · Culdoscope (And Accessories)4 reports
- Advincula Delineator™ Uterine Manipulator with 3.5 cm Ultem® Koh-Efficient® AD750-KE35Coopersurgical, Inc. · Culdoscope (And Accessories)3 reports
- Arch Koh-Efficient KC-ARCH-30Coopersurgical, Inc. · Culdoscope (And Accessories)3 reports
- USA Series G27L-30WAGyrus ACMI, LLC · Culdoscope (And Accessories)3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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